PMA P150001S076

Device: Medtronic MiniMed 630G System
Applicant: Medtronic Minimed
PMA number: P150001
Supplement: S076
Product code: OZO
Decision date: 2019-11-04
Classification: Automated Insulin Dosing , Threshold Suspend
Generic name: Automated insulin dosing , threshold suspend
Approval order statement: Packaging, labeling, and final release activities of the One-Press Serter conducted at Medtronic, Inc. to be moved to contract manufacturer facility. The One-Press Serter is a component of the 530G System, the 630G System, the 670G System, and the Guardian Connect System.

Current openFDA PMA Record#

Device: Medtronic MiniMed 630G System
Applicant: Medtronic Minimed
PMA number: P150001
Supplement: S076
Product code: OZO
Generic name: Automated insulin dosing , threshold suspend
Decision date: 2019-11-04
Decision code: OK30
Date received: 2019-10-11
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Packaging, labeling, and final release activities of the One-Press Serter conducted at Medtronic, Inc. to be moved to contract manufacturer facility. The One-Press Serter is a component of the 530G System, the 630G System, the 670G System, and the Guardian Connect System.